| 摘要 |
A dosage form in the form of a capsule, cachet, sachet, tablet, tape or laminate for oral administration of one or more active substances, the dosage form comprising a vehicle comprising
i) a gellan gum that is acylated within a degree of up to 4 per every two repeats of the glucose-rhamnose-glucose-glucoronic acid unit of the polymer, and
ii) a hydrophilic agent selected from the group consisting of electrolytes, organic acids and osmotic agents, and mixtures thereof, to improve swelling of the gellan gum,
wherein the vehicle upon addition of a predetermined amount of an aqueous medium, without the necessity of applying shear forces or other mixing forces, within a time period of 5 minutes or less swells and/or gels and the swelled composition has a viscosity of at least 10,000 mPa s (10,000 cps) as measured by a Brookfield Viscometer with a #4 LV spindle at 6 rpm and at 20-25 °C, when into a 500 ml beaker 22 - 88 g test material is accurately weighed, 500 ml tapped water is added, mix until all the material is dispersed/dissolved, and after 5 min the viscosity and the temperature are measured, wherein the Viscometer spindle is centered in the test sample container, the spindle is properly immersed to the mid-point of the shafts narrow portion; and
wherein the dosage form is capable of being converted to a semi-solid form by addition of an aqueous medium before oral administration. |
